JP2002513652A - Removal device assembly to be irrigated - Google Patents

Abstract

A tissue ablation device assembly ablates a region of tissue in a body of a patient. The tissue ablation device assembly comprises an elongated body having a proximal end portion and a distal end portion. A tubular porous membrane having a porous wall with an inner surface that defines an inner space is located along the distal end portion of the elongated body. An ablation element is disposed over the porous membrane, with the ablation element having a fixed position with respect to the porous membrane. A fluid passageway extending through the elongated body and communicates with the inner space. The fluid passageway is adapted to be fluidly coupled to a pressurizeable fluid source for delivering a volume of pressurized fluid from the fluid source to the inner space. The porous membrane allows at least a substantial portion of the volume of pressurized fluid to pass through the porous wall for enhancing ablative coupling between the electrode and the region of tissue.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001] FIELD OF THE INVENTION The present invention relates to surgical devices. More particularly, the present invention relates to a tissue removal device assembly having a cleaned removal member adapted to cause scarring in tissue. The invention also relates to the production of the removal element. 2. Description of the Related Art Cardiac arrhythmias, and especially atrial fibrillation, remain a medical condition that does not go away in modern society. Persistence of atrial fibrillation may be due to congestive heart failure, stroke, and other thromboembolic events.
o, It has been observed to cause, or at least contribute to, various medical conditions, including myocardial ischemia.

[0002] To treat or prevent cardiac arrhythmias, particularly for the treatment of atrial fibrillation, especially recently, Thoracic and Cardiovascular Sur
Gerry 101 (3), pp. 402-405 (1991), “Surgical Treatment of Atrial Fibrillation, I, Overview (The surgical treatment o).
fatal fibrillation, I, Summery) "and Thoracic and Cardiovascular Surgery.
101 (4), 584-592 (1991), “Surgical treatment of atrial fibrillation, IV, surgical technique (The surgical treatment of atrial fibrillation).
atrial fibrillation, IV, Surgical Tec
hnique) "by M.C., JL et al.
Several surgical techniques have been developed, such as according to one example known as "aze procedure". In general, a "maze" procedure is configured to mitigate cardiac arrhythmias by incising the heart tissue wall in a designated configuration and restoring effective atrial contraction and sinus node control. In the clinical experience reported earlier, the "maze" procedure involved surgical incisions in both the left and right ventricles. However, only recent reports have shown that surgical "maze" procedures have been described by Sueda et al., "Simple left atrial treatment of chronic atrial fibrillation associated with mitral valve disease.
left Atrial Procedure for Chronic Atr
ial Fibrillation Associated With Mit
ral Valve Disease) (1996), and is expected to be quite effective when performed only in the left atrium.

[0003] The "maze procedure" performed in the left atrium involves making a vertical incision from the two upper pulmonary veins, passing through the lower pulmonary veins, and mimicting the mitral valve vein.
(nullus) region. 2 additional horizontal lines
It also connects the upper ends of the two vertical cuts. The atrial wall region bounded by the pulmonary vein opening is then separated from other atrial tissue. In this procedure, atrial tissue and mechanical cutting eliminates precipitating conduction for atrial arrhythmias by providing a conduction block in the stray conduction path.

[0004] Although surgical procedures such as the "maze" procedure have been reasonably successful in treating atrial arrhythmias, it is believed that this highly invasive method is often not feasible. However. Their approach is to treat impaired cardiac tissue—atrial arrhythmias when electrically isolated, and, in particular, a constantly winding concave wavelet.
ring reentrant wavelet) or alizogenetic
It provides the principle that successful prevention of atrial fibrillation caused by the focal region of the arrhythmic conduction can be achieved. Thus, the development of a minimally invasive catheter-based procedure for treating atrial fibrillation by heart tissue removal was intended to emulate a maze-type procedure.

[0005] In general, known catheter-based treatments for cardiac arrhythmias are such that an energy sink at the distal end of the catheter is located at or near tissue with abnormal electrical conductivity. This involves inserting a catheter into the ventricle, such as in a translumenal procedure through the skin. The energy sink is activated according to various known surgical methods so that the targeted tissue near it is removed and does not propagate the heart rhythm.

[0006] One particular type of energy sink disclosed for use as an ablation element to remove tissue by use of heat conduction is, for example, a current flow through a closed loop system in an ablation catheter. It is a heat sink that removes tissue by using heat conduction by a resistance wire that sometimes generates heat. The disclosed threshold temperature for removing tissue according to the heat transfer removal mode is generally greater than or equal to 45 degrees, typically 45 degrees.
Degrees to 74 degrees, usually 50 to 65 degrees C, preferably about 53 to 60 degrees C. It has also been observed that high temperatures, such as temperatures above 70 degrees, can cause scorching at the boundaries of the tissue removal element. It has also been observed that such scorching can have adverse medical consequences, such as thrombus formation on the walls of tissue in the case of removal of ventricular tissue, including the atrium.

[0007] Another previously disclosed energy sink for use as an ablation element is located near the targeted tissue and is coupled to the return electrode by the body's own conductivity and is connected to the distal end of the catheter. Include electrodes that produce a direct current (DC), such as from an electrode at the end. However, disclosed for use in tissue removal devices and methods,
More recent current-based ablation elements have instead used electrodes driven by radio frequency (RF) current. With RF electrode removal, the electrodes can be placed near the target tissue and placed on the same or a different invasive device, or more commonly as a large surface area conductive patch on the patient. It is electrically coupled to a provided return electrode. The current flowing between the electrode and the patch is at the highest density in the tissue near the treatment electrode, thus causing that tissue to be removed. This configuration is adapted to remove tissue by heat conduction at the electrode-tissue interface, and furthermore to cause tissue or resistive or dielectric heating of the tissue itself in the high current density regions of the RF current path. Being able to remove heat.

In addition to the energy sink just described for use as a tissue removal element, other energy sources disclosed for use in catheter-based ablation methods include microwave energy sources, cryoblation ( cryoblati
on) Includes energy sources, light energy sources, and ultrasonic energy sources.

[0009] Various specific catheter-based removal tools and methods have also been disclosed for creating specific shaped or patterned lesions in target tissue. In particular, various known tissue removal devices have been used to focus regions (foca) in the wall tissue making up the ventricle.
l region or a straight (including curved) region.

[0010] Points to eliminate portions of abnormal electrical activity, such as where the atrial fibrillation is believed to be focal, where the affected arrhythmia begins in the left ventricular pulmonary vein, etc. A less invasive percutaneous catheter removal device and technique using a modified version of the "end-electrode" catheter configuration for delivering a source of energy is disclosed. The end electrodes form a localized wound that removes the affected area and treats by removing such affected arrhythmias, such as in the pulmonary veins. Previously disclosed therapeutic lesion removal methods for removing lesions in the pulmonary vein can be found in the following literature. Journal of Cardiovascull
ar Electrophysiology 7 (12), pp. 139-143. 1132-1
144 (1996), Haissaguerre et al., "Right and Left Atrial Radiofrequency Catheter Treatment of Paroxysmal Atrial Fibrillation (Right and Left Rad).
Iofrequence Therapy Therapy of Paro
xymal Atrial Fibrillation) "and Circ
Jais et al., “Affected Source of Atrial Fibrillation Treated by Individual Radio Frequency Ablation” (A focal sou), ed. 95: 572-576 (1997).
rce of atrial fibrillation treated b
y discrete radiofrequency ablation) "
.

[0011] However, affected tissue removal involves a multi-wlet (multi-wlet) that includes a number of reentrant loops that are believed to arise from various arrhythmia sources.
(averet) type is not generally believed to be appropriate for many cases of atrial fibrillation. These multiple stimulus waves are caused by the removal of lesions in the heart tissue.
it simply passes through the abrasive version. Therefore, similar to the surgical "maze" procedure described above, a continuous straight wound is needed to completely divide atrial tissue to block the wavefront associated with most atrial fibrillation. It is believed that there is. Accordingly, certain other tissue removal devices have also been disclosed that are adapted to be straightened for the specific purpose of processing and blocking this multi-wavelet of atrial fibrillation.

In order to make a straight wound at one distal electrode tip that is adapted to pull along a tissue wall or to form a series of point wounds, a "pull" assembly and a "pull" The use of various tissue removal devices and methods, referred to as methods, is disclosed. According to one or a maintained form of true pulling, the tip of the catheter is pulled across the tissue along a predetermined path within the heart as RF energy is applied. Alternatively, a line of removal using the distal tip electrode catheter assembly can be created by sequential placement and removal along the path.

In one particular example, which is intended to use a single point electrode catheter assembly to make a straight wound in a maze style, bending along a predetermined path of the tissue to be removed A shaped guide sheath is used to place the end electrode on a ready or shaped catheter. In accordance with the disclosed assembly and method, continuous transcutaneous operation by remote percutaneous operation only using x-ray fluoroscopy equipment to make the catheter location in the beating ventricle visible. Mural wounds must be made. Further, it has been observed that this method may fail to make continuous transmural wounds, thereby leaving the opportunity for re-entrant circuits to reappear in gaps remaining between injuries or pulling injuries.

Further, a further layer of a tissue removal device assembly that uses a sequential supply of energy from a point on a remotely operated catheter to create an ablation maze according to a predetermined pattern, such as in accordance with the example just described. A detailed example is disclosed in the following document. U.S. Patent No. 5,427,119 to Swartz et al.
U.S. Patent No. 5,564,440 to Zartz et al., U.S. Patent No. 5,576,766 to Swartz et al., U.S. Patent No. 5 to Swartz et al.
, 960, 611.

[0015] In addition to the "pull" type method described above, which uses an end electrode catheter to create a straight wound, to form a line of conductive block along the ventricular wall tissue near the multi-electrode compartment Another assembly is disclosed that provides multiple electrodes along the length of the distal end portion of the catheter. These catheter assemblies generally include a plurality of ring or coil electrodes surrounding the catheter at spaced intervals extending from the distal tip of the catheter toward the base.

In accordance with some disclosed examples of this type of “multi-electrode” tissue removal device (and also in accordance with various configurations of the “end electrode” type), a straight catheter is placed over the catheter. A tip that can be manipulated is provided. These catheters generally include one or more steering lines that extend from a steering mechanism at the proximal end of the catheter to an anchor point at the distal end of the catheter. By tensioning the steering line or lines, the distal end of the catheter on which the electrodes are provided can be at least partially directed in a desired orientation to a plane. The distal end of the catheter can be bent at least along it. In addition, at least one known tissue removal catheter has a rotatable steering mechanism that allows manipulating the proximal end of the catheter to rotate the distal end of the catheter about the longitudinal axis of the catheter. . Once the catheter is steered according to the various assemblies disclosed and placed against a predetermined area of body tissue within the body chamber, the removal element can be activated and wounded.

[0017] A tissue removal device assembly is also provided wherein the catheter having a predetermined bend is received within a sheath advanced over the distal end of the catheter. As the catheter advances within the sheath, the predetermined curvature of the distal end of the catheter is changed. Various shapes are created for the distal end of the catheter by inserting variously shaped catheters through the external guiding catheter. Other straight wound assemblies disclosed include preformed catheters having electrodes along the shaped portion, including "hairpins" or "J-shaped".

A more detailed example of a catheter-based tissue removal device and method for making a long, straight wound along the wall of the ventricle into an obturator, such as in accordance with at least some examples just described, is as follows: It is disclosed in the disclosure document. U.S. Pat. No. 5,545,193 to Fleischman et al., U.S. Pat. No. 5,549,661 to Kords et al., And U.S. Pat. No. 5,617 to Munsif.
, 854, PCT Publication WO 94/21165 to Kords et al. And PCT Publication WO 96/26675 to Klein et al.

During a tissue removal operation, particularly an RF ablation-type tissue removal operation, the removal of one or more ablation electrodes on the heart tissue to create a continuous, straight wound to properly treat the arrhythmia condition. It is important to maintain correct placement and correct contact pressure. Thus, the most recently disclosed catheter-based cardiac tissue removal assemblies and methods provide for manipulating the removal element and accurately and reliably positioning it at a desired location within the ventricle, and especially within those chambers. It is intended to include a more complex mechanism for forming the desired wound shape. This type of catheter, previously disclosed, is a three-dimensional basket structure, in which a plurality of splines are intended to be held in place along the tissue by a basket that is inflated in the atrium. A three-dimensional basket structure having one or multiple electrodes that can move freely, an instrument having a bendable electrode section with adjustable coil length, capable of forming a convoluted wound of varying length, A composite structure that can be variously bent along its length to form various bent shapes from an overall straight shape, expanding when exiting the distal end opening of an elongated catheter A diverging spline constrained nearby, having multiple electrode elements extending between them, a spline, a probe instrument, and out of the probe Probe device having a removal element that is to be bent to a desired region of the selfish tissue, and comprises an instrument having an electrode device which is elongated to an external delivery sheath. The electrode device of this device is such that, when the electrode device is manipulated at hand, the multiple electrodes at the distal end of the device are delivered and arched outward from the distal end of the sheath, or `` bent '' into the inner lumen of the delivery sheath. It is slidably arranged.

[0020] Various more detailed examples of catheter-based tissue removal assemblies and methods for making long, straight lesions on heart tissue, such as in accordance with the types just described, have been variously disclosed in the following references: I have. U.S. Pat.
U.S. Patent No. 5,575,81 to Swanson et al.
No. 0, PCT published application WO 96/10961 to Fleischman et al., A
US Pat. No. 5,487,385 to vtail, US Pat. No. 5,702,438 to Avtail, US Pat. No. 5,687,723 to Avtail, PCT publication to Schaer. Application WO 97/3760
7.

In addition to those known assemblies just summarized above, at least one predetermined location along a length of tissue, such as to create a “maze” type wound pattern in the left atrium Tissue removal instrument assemblies have also recently been developed for the specific purpose of securing a secure removal element such that the element is in strong contact along its length and secure placement. One example of such an assembly is to allow tissue to be removed along the length of tissue extending between the two ends of the straight removal element.
A swath includes an anchor at each end to secure their ends at each of two predetermined locations along the left atrial wall, such as in two pulmonary veins.

Fluid Irrigated Removal Element In addition to the various catheter and removal element configurations described above in accordance with various known tissue removal device assemblies, the removal response of the tissue at the tissue-to-removal element interface is also described. Other assemblies are disclosed that provide a means of coupling the removal element to a controlled flow of fluid for the purpose of strengthening. The element so obtained is referred to as a "fluid irrigated" removal element or electrode.

For example, a hollow body organ (the disclosed examples include a masticum, an appendix, a uterus, a kidney) or a hollow body passageway (the disclosed examples include a blood vessel, and a fistula) One previously disclosed tissue removal device, intended for heat removal of those organs, is to provide a thermally conductive fluid medium flowing through a resistive heating wire wound over the catheter body. Provides a controlled flow of The thermally conductive fluid medium is intended to equalize and enhance the heat transfer from the resistive heater coil and to reduce the time required to raise the medium temperature to the treatment temperature by 37 degrees. Provided for heater coils at temperatures from C to 45 degrees C. In one particular variation of the disclosed assembly and method, fluid flows from the tube through an opening between one turn of a wire wound around the tube. In another disclosed variation of this example, the fluid flows through a heating element, which may be a perforated or permeable structure, such as a wire mesh or other perforated cylindrical structure. In yet another disclosed variation, the flow of the fluid medium is oscillating. In this case, the volume of the fluid is alternately injected and withdrawn from the area of the heater coil to control the temperature in that area.

A conductive fluid medium is thermally coupled to the resistive heating element to enhance heat transfer to the tissue. More detailed examples of those tissue removal device assemblies and methods are provided by Nichols
No. 5,433,708 to others.

[0025] Other previously disclosed tissue removal devices, especially RF electrode type removal devices, are also at least partially due to the narrow temperature range for removal, as described above. In addition, fluid is also coupled to the interface between the tissue and the ablation element, such as for the intended purpose of cooling the tissue during RF ablation. In order to control the temperature at the tissue-to-removal element boundary during removal according to the intended fluid cooling function, for example, flow to or to the removal element based on the temperature or impedance measured at the tissue boundary Various other means are also disclosed, including assemblies that use feedback control of the amount of energy or current flowing from the device.
Also, another intended result for the previously disclosed RF electrode assembly to be irrigated with a fluid, particularly a multi-electrode assembly for forming a straight maze wound as described above, is: The uniform distribution of the density of current flowing into tissue along the length of the RF ablation element.

For example, some previously disclosed fluid-coupled RF removal assemblies and methods circulate fluid inside a catheter, including through a chamber formed by the inner surface or lining of an electrode. Thereby, a fluid is used to cool the electrode elements during RF ablation. Such an assembly is intended to cool the tissue-electrode interface by cooling the electrode itself during removal, including of the "end electrode" type, with a bendable tip / orientation. Further comprising such an assembly of operable mechanisms,
In addition, it includes an assembly that is adapted to a larger surface removal element to make a large wound, such as to make a straight wound in a maze fashion. In another example disclosed, a passive heat conducting means is coupled inside the end electrode. The means consist of a fibrous material such as cotton fibers impregnated with a heat absorbing fluid such as salt or water. As the end electrode is heated during removal, heat is transferred from the electrode to the passive heat transfer means where it is dissipated toward the cooler portions.

Another disclosed variation of a fluid cooled RF ablation assembly is to provide a port through which the cooling fluid flows as it flows out of the catheter to enhance cooling heat transfer from the electrodes to the cooling fluid. Contains. In one known example of this type, fluid flows through an opening in the ablation catheter near the electrode, and in another disclosed variant, fluid flows through an opening in the electrode itself. In another previously disclosed end electrode type tissue removal assembly, a plurality of lumens include a distal port near the end electrode. The lumens allow the cooling fluid to flow over the outer surface of the electrode near the tissue-electrode interface at the tip of the electrode.

Another example of a known tissue removal assembly that uses a fluid-irrigated electrode is to direct the fluid irrigation directly to the tissue-electrode interface. In one known example of this type, an opening is formed in the distal arcuate surface or tip of a metal end electrode that is intended to contact the target tissue. This assembly, during removal,
It is intended to provide a passage for the fluid formed by the end electrodes and circulating in the ethyl chamber to flow into the tissue-electrode interface.

[0029] A tissue removal device intended to remove the inner layers of body organs, more specifically the endometrium, comprises an inflatable member containing an electrolyte, such as saline. I have. The balloon has a rear side and a front side provided with a plurality of openings. The electrolyte is allowed to selectively flow from the interior through the opening at a flow rate that depends on the pressure applied to the balloon by the electrolyte. The mating member includes a conductive surface and a rearwardly directed front side which is perforated with the balloon. The mating members are also disclosed to be 0.01 centimeters and 2.0 centimeters thick, and are fitted with silicone-reinforced natural rubber, neoprene, soft to fit the uneven inner surface of the uterus It can be made of open-cell foam materials such as rubbery and polyurethane materials or thermoplastic film materials. This disclosed structure for the conductive surface of a matching member includes extruded conductive material, conductive ions implanted into the member, or a conductive surface coating such as in the form of a printed circuit that constitutes the member itself. . According to another alternative embodiment of the assembly, a relatively strong membrane can be placed between the balloon and the mating member. The membrane passes the electrolyte from the balloon to the mating member. It is disclosed that the selected membrane is made of a microporous material such as expanded PFT such as Gortex available from Mylar, Gore.

According to the disclosed use of this assembly, the back side of the balloon pushes inside the uterus.
As the pressure inside the balloon rises with the electrolyte fluid, the mating members face the opposing walls of the endometrium. The combination of a mating member and the delivery of an electrolyte solution through the mating member is further disclosed for effectively delivering RF energy to the endometrium.

In another disclosed variation of the endometrial removal device just described, a balloon having a plurality of perforations in its hull has a particular shape that approximates the shape of the intrauterine space when inflated. Have. A mating member, similar to the type just described for the conventional assembly, is provided about the outer surface of the balloon and adapted to conform to the uterus by compression. A printed circuit is provided as an ablation element, which can be formed inside or on the mating member or behind or near the conducting surface, and supplies RF energy to selected portions of the uterus. During removal, fluid flows into the uterus through the hole in the balloon and through the mating foam member. Also disclosed is an optional porous membrane disposed between the mating member and the balloon.

Various additional variations of the uterine removal assembly just described are also disclosed. In one such disclosure, the inflatable member that makes up the balloon can be made of a microporous material that does not contain well-defined holes. Other disclosed structures to allow the cellular mating member to be molded and molded to conform to the uneven surface of the uterus include woven polyester, continuous fiber polyester, polyester cellulose, rayon, and the like. , Polyimide, polyurethane, and polyethylene. In yet another disclosed embodiment, two mating members are provided around the electrode to increase the temperature of the electrode and retain the electrolyte at the electrode to achieve a greater removal electrode effect. By sealing together, a low porosity area can be formed along the outer surface of the device. In one more detailed disclosure of this configuration, two Ultrasorbs (UltraS
orb) foam about 0.004 inch x 0.041 cm (0.04 cm x 0.041 cm)
Sealed between 16 "flat electrode wires, about 1.0" SST wire was exposed in the foam. Another disclosed foam size of this type is (i) about 0.159 cm x 0.318 cm (1/16 inch x 1/8)
Inches), (ii) about 0.318 cm x 0.159 cm (1/8 inch x 1/1
6 inches), (iii) about 0.159 cm x 0.159 cm (1/16 inch x
1/16 inch). Here the size of the bubble is about 2.5cm x 2.5c
m (approximately 1.0 inch × 1.0 inch).

Another example of a known fluid-irrigated tissue removal electrode device intended for use in a labyrinth-style straight wound in the atrium is to place the area of the removal element on the inner surface of the atrium. It contains a straight wound electrode element that is irrigated with fluid on a catheter with a removable pre-shaped probe needle intended to be matched. A foam layer formed of open-cell polyurethane, cotton-like material, open-cell sponge, or hydrogel is placed over the electrode element, is permeable by the conductive fluid, and exhibits some compressibility. The foam layer is encapsulated in a fluid-tight coating containing a plurality of small holes intended to assist in focusing RF energy to target tissue in the heart. The coating can be heat shrink polyethylene, silicone, or
It consists of a conductive wire or other polymer material consisting of a flat conductive ribbon that is insulated but separated at intervals separated along the stripped portion. During removal, the conductive fluid flows through a lumen in the catheter shaft and through a hole in the catheter shaft to a compressible foam layer over the electrode element and through the perforated coating. The electrode element of this variant consists of a conducting wire or a flat conducting ribbon extending along a lumen with selected insulating parts and uninsulated parts.

[0034] Yet another known tissue removal device intended to make a straight maze-type wound in the atrium is that a removal portion on one side of a loop adapted to be placed in the heart. , Including using an electrode along the loop that is irrigated with fluid to effect this on the opposite wall of the atrium by the opposite action of the loop on the wall of the atrium. A plurality of electrodes are disposed on the perforated injection tube.
A compressible foam layer is placed over the electrode and covered with a discretely perforated coating. During removal, fluid flows from the infusion tube through the holes in the tube, the energized electrode, and the foam layer, and finally out through the holes in the outer coating. A conductive fluid, such as a conductive salt, can be used to create a conductive path between the electrode and the target tissue and to cool the removal electrode.

Another more detailed example of an ablation device for flowing fluid between an electrode and tissue when current flows from the electrode to tissue, such as according to the example just described, is disclosed in the following document: . U.S. Patent No. 5,348,544 to Imran et al., U.S. Patent No. 5,423,811 to Imran et al., U.S. Patent No. 5,505,730 to Edwards et al., Imran et al. US Patent No.
No. 54,161, US Pat. No. 5,558,672 to Edwards et al.
No. 5,569,241 to Edwards et al., Bake.
U.S. Patent No. 5,575,788 to Imran et al .; U.S. Patent No. 5,658,278 to Imran et al .; U.S. Patent No. 5 to Panescu et al.
U.S. Patent No. 5,697,927 to Imran et al.
No., PCT Patent Application Publication No. to Pomeranz et al. WO 97/32525,
And PCT Patent Application Publication No. WO 98/02201
.

[0036] Any of the cited documents are passed through a source of compressible fluid to irrigate fluid along the length of the element in a similar manner at the interface between the tissue and the removal element. Covered by one thin layer of a porous fluid permeable membrane,
It does not disclose a tissue removal member having a wrapped length of the removal element.

The cited document also discloses that the removal element along the removal device is disposed in a portion that is permeable to fluid so that the conductive fluid can be transmitted over the removal device in the tube, over the removal element, and far away. Said permeation adapted to slidably receive a tissue removal device so that it can flow outwardly through the possible portion and be injected along the fluid permeable portion into the boundary between the tissue and the removal element. It does not disclose a tubular member having a possible portion.

SUMMARY OF THE INVENTION The present invention is directed to a medical device assembly for removing body wall tissue that at least partially defines a body space within a patient.

One aspect of the invention is a removal member having at least one removal element, at least one conductor coupled to and extending proximate to the removal element, and at least one porous membrane. And a tissue removal device assembly comprising: A porous membrane having a generally incompressible porous wall having an inner surface that defines an interior space and having a porous wall disposed relative to each other with respect to a removal element is provided with a certain amount of fluid. The inner space is allowed to flow through the porous wall into the outer space surrounding the porous wall without changing the relative arrangement between the porous wall and the removal element. The removal element is positioned sufficiently close to the porous membrane such that the removal element is adapted to be coupled to the area of tissue for removal via that volume of fluid flowing through the wall. Also, at least one fluid compressible passage of the removal member communicates with the interior space.

In one variant of this assembly, the porous membrane covers a removal element located in the interior space. In another variation of this assembly, at least a portion of the removal element is outside the porous membrane. In each case, the assembly allows for irrigation of the electrode with multiple layers.

In an additional variation of this assembly, the removal member is located at the distal end of the elongated body. A first anchor and a second anchor are disposed on the elongated body, and a removal member is disposed between the anchors. In this variant,
The at least one anchor is a guide member tracking member that forms a corresponding portion that defines a hole that is adapted to advance over the elongated body of the guide member.

Another aspect of the invention is a tissue that includes a removal member having a removal element, at least one conductor coupled to and extending proximate to the removal element, and at least one porous membrane. It is a removal instrument assembly. The porous membrane has a generally incompressible porous wall having an inner surface that defines an interior space and covers a removal element disposed within the interior space. The removal member also includes at least one compressible fluid passage leading to the interior space. The porous membrane is adapted to allow an amount of compressed fluid to pass from the interior space through the porous wall to the exterior of the removal member.

In a variation of this assembly, the tissue removal device assembly further includes an elongated body having a proximal end portion and a distal end portion. A removal member is included on the distal end portion of the elongated body. A compressible fluid passage extends between the near fluid port along the proximal end portion of the elongated body and the interior space within the porous membrane. A conductor extending proximally from the removal element terminates proximally along the proximal end portion of the elongated body.

[0044] An additional aspect of the invention includes a tissue removal device assembly that includes a sheath member having a proximal end portion and a distal end portion. The sheath member is a porous membrane, a fluid delivery passage,
And a near fluid coupler. The porous membrane has a polynomial wall adapted to be positioned within the patient's body space by manipulating the proximal end portion of the sheath member external to the patient. The porous membrane forms an internal space. The space is sized to slidably receive the distal end of the catheter. The interior space is at least partially constituted by the inner surface of the porous wall. The porous membrane is capable of compressing a certain volume of fluid in the internal space to a predetermined pressure, and sends the fluid from the internal space to the outside of the sheath member through the porous wall. A fluid delivery passage extends from the interior space to a near port. The port is located on the proximal end portion of the sheath member. Disposed on the proximal end portion, the fluid coupler is adapted to fluidly couple the proximal port to a source of compressed fluid.

In one variation of this assembly, the tissue removal device assembly also includes a removal catheter having an outer surface, a proximal end portion, and a distal end portion having a removal element. A conductor is coupled to and extends proximally from the removal element and terminates proximally along the proximal end portion of the removal catheter. A near reject coupler couples the conductor and the reject element to the reject actuator. A source of compressed fluid is coupled to the near fluid coupler. The distal end portion of the ablation catheter can position the ablation element inside the porous wall such that a volume of fluid from the compressed fluid source passes between the outer surface of the ablation catheter and the inner surface of the fluid delivery passage. So as to slidably engage the porous member.

Another aspect of the invention is a method of making an elongated clothing device. The method includes providing a first tubular member and a second tubular member. At least one opening is formed in a section of the first tubular member. The section of the first tubular member is at least partially disposed over the second tubular member. A sealing member of a material compatible with the material of the second tubular member is provided, and the sealing member is disposed on at least a portion of that section of the first tubular member. The sealing member is fused to the second tubular member to form a fused assembly. A portion of the fused assembly extends through an opening formed in that section of the first tubular member to secure the first and second tubular members together.

Another aspect of the invention includes a tissue removal device assembly adapted to remove an area of tissue within a body space wall of a patient. The tissue removal device assembly includes at least one
A removing member including two removing elements. At least one porous membrane having generally incompressible porous walls has an inner surface defining an interior space. The porous wall and the removal element are arranged relative to each other. At least one fluid passage leads to the interior space and the porous membrane. A certain amount of fluid from the interior space through the porous wall,
It is possible to flow into the external space surrounding the porous wall without changing the relative arrangement between the porous wall and the removal element. The removal element is
The removal element is sufficiently close to the porous membrane so that the removal element is made hot water that removably binds to the area of tissue via that amount of fluid flowing through the wall.

[0048] Other aspects, features and advantages of the present invention will now be apparent from the following detailed description of the preferred embodiments.

The above and other features of the present invention will be described below with reference to the drawings of a preferred embodiment of the tissue removal instrument assembly of the present invention. The described embodiments are illustrative and are not intended to limit the present invention.

Detailed Description of the Preferred Embodiment FIG. 1 shows an irrigated removal member 12 constructed in accordance with a preferred variation of the present invention.
1 shows a tissue removal device assembly 10 having a. This removal member 12 has particular utility in connection with making straight lesions in the myocardial tissue of the left atrium of a mammalian heart. Those skilled in the art will appreciate that this application of the removal member is merely exemplary and that the irrigated removal member 1212 can be readily adapted for other body space applications and removal of other forms of wound. Will.

The removal member 12 is attached to the delivery member 14 to place the removal element 12 closer to the side of the target tissue. In the embodiment shown, the delivery member is in the form of an example of an over-the-wire catheter. Delivery member 14 includes an elongated body 16 having a proximal end portion 18 and a distal end portion 20. As used herein, the terms "far" and "near" are used with reference to a fluid source that is located outside the patient's body. The elongated body 16 includes a guide member lumen 22 and an electrical lead lumen 24.
And a fluid lumen 26. These lumens are described in more detail below.

Each lumen extends between a near port and a respective distal end 20. In the embodiment shown, the distal end of the lumen extends through the removal member 12, as described in more detail below. Although the guide member lumen 22, electrical lead lumen 24, and fluid lumen 26 are shown in a side-by-side relationship, the elongated body 16 has one or more of the lumens disposed in a coaxial relationship. Or any of a wide variety of configurations that will be apparent to those skilled in the art.

The elongated body 16 of the delivery member and the remotely located removal member 12 are preferably inserted into the left atrium by a transcutaneous translumen method, more preferably by a transeptal method. Desirably, it is inserted. Thus, the distal end portion 20 and the removal member 12 of the elongated body 16 can be fully flexed, located in the right and left atriums, and more preferably the lungs leading to the left atrium. It is adapted to pass over and along a guide member located within one of the veins. In the exemplary configuration, the proximal end portion 18 of the elongated body is at least 3 times less than the distal end portion 20.
It is configured to be 0% or more hard. In accordance with this relationship, the proximal end portion 18 can be suitably adapted to provide a push transmission against the distal end portion 20, and the distal end portion and the removal member 12 can be created into the desired removal area. Bending structure (b
It has been appropriately adapted to comply with the ending anatomy.

A more detailed description of the components of the elongated body 16 that are believed to be suitable for use in the transeptal left atrial ablation procedure follows. The elongated body 16 itself has a diameter of about 3 French.
ch) to about 11 French, more preferably from about 7 French to about 9 French. The guide member lumen 22 has a diameter of about 0.025 cm.
Preferably, the guide member is slidably received in a range of from about 0.010 inches to about 0.038 inches to about 0.0097 cm, and has a diameter of about 0.3 mm.
Preferably, it is adapted for use with a guide member ranging from about 0.018 inches to about 0.035 inches. About 0.0
If a 089 cm (about 0.035 inch) guide member is to be used, the inner diameter of the guide member lumen 22 may be from about 0.102 cm to about 0.107 cm (0.040 inch to about 0.042 inch). desirable. In order to allow sufficient irrigation of the removal member 12, the inner diameter of the fluid lumen 26 is about 0.048 cm.
(Approximately 0.019 inches).

In the embodiment shown, the elongated body 16 comprises at least three tubings, namely, an electrical reed 30, a fluid conduit 32, a guide member conduit 34, as best seen in FIG. Having an outer tubular member 28 for receiving the same. As explained below,
Each tube is at least elongated from a proximal end portion 18 to a distal end portion 20 of the body.
At least through the removal member 12. Although the tubing is arranged in a side-by-side configuration, one or more tubing can be arranged in a coaxial configuration, as described above. In one aspect, the inner tubing is a polyimide tubing. Such tubing is commercially available from Phelps Dogges, Trenton, JJ. The inner diameter of the electric lead 30 and the fluid pipe 32 is about 0.048 cm (about 0.048 cm).
Desirably, the outer diameter is about 0.023 inches (19 inches) and, as noted above, the guide tube 34 is slightly larger. The outer tubular member 28
For example, it is composed of a thermoplastic such as urethane or vinyl material. A suitable material for this application is Pebax, a grade between 3533 and 7233, having an outer diameter of about 0.064 inches.

Despite the particular delivery device configuration just described, other delivery mechanisms for delivering the removal member 12 to a desired removal area are also contemplated. For example, FIGS. 1-3 show variations that are shown as "on-the-line" catheter configurations, for example, "quick", where the guide member is only housed within the catheter lumen in the distal region of the catheter. Other guide tracking structures are also suitable alternatives, such as catheter devices known as "exchange" or "monorail" types.
In other examples, a bendable tip configuration is a suitable alternative. The latter structure may also include a pull wire adapted to bend the catheter tip by applying tension along a changing stiffness transition along the length of the catheter.

The proximal end portion 18 of the elongated body terminates in a coupler 36. In general, any of several known configurations of the coupler are suitable for use in this tissue removal device assembly, as will be apparent to those skilled in the art. In the variant shown in FIG. 1, the proximal coupler 36 engages the proximal end portion 18 of the elongated body of the delivery member. The coupler 36 electrically couples one or more conductor leads extending from the removal member 12 and extending through the electrical lead tube 39 to a removal actuator 40 (shown schematically in FIG. 1). Electrical connector 38. Coupler 36
Also preferably includes an electrical connector 39 for electrically coupling one or more temperature sensor signal lines 42 (shown in FIG. 3) to the controller of the removal actuator 40.

As is known in the art, the removal actuator 40 is connected to electrical connectors 38 and 39 and to a ground patch 44 as shown schematically in FIG. This forms a circuit including the removal actuator 40, the removal member 12, the patient's body (not shown), and the ground patch 44 that grounds or floats the current source. In this circuit, a current, such as a radio frequency ("RF") signal, can be passed through the patient between the removal member 12 and the ground patch 44, as is well known in the art.

The coupler 36 also includes a fluid coupler 46. The fluid coupler 46 is adapted to be coupled to a source of compressed fluid (eg, a salt solution) to irrigate the removal member 12 as described below. In the example shown in FIG. 1, the fluid coupler 46 supplies a compressed fluid (not shown) to the removal member 12 through the fluid line 32.

Referring now to FIGS. 1-3, the shape of the removal member 12 is generally tubular and includes a removal element 50. As used herein, the term "removal element" refers to an element that is adapted to substantially remove tissue within a body space wall when actuated by an actuator. The terms "removing" or "removing", including derivatives thereof, are used hereinafter to mean a sufficient change in the mechanical, electrical, chemical, or other structural properties of a tissue. It is intended. In the context of an endocardial ablation application, shown and described with reference to variations of the embodiments described below, "ablation" is sufficient to allow the conduction of electrical signals from or through the heart tissue to be ablated. It is intended to mean changing the nature of the tissue until it is stopped. The term "element" in the context of "removal element" is used herein to refer to an individual element, such as an electrode, or a plurality of separated electrode names arranged to remove tissue in an area together. It is intended to mean multiple individual elements of a degree. Therefore, "removal elements" according to defined terms include:
Various specific structures that are adapted to remove defined areas of tissue may be included. For example, one suitable ablation element for use in the present invention may be coupled to an energy source and release sufficient energy to remove tissue when energized thereby, in accordance with the teachings of the following embodiments. It can be formed from the "energy release" type that has been described.

[0061] "Energy emitting" type abatement elements suitable for use in the present invention include, but are not limited to, direct current ("DC") sources, or radio frequency ("RF") sources, and microwave energy sources. Antenna element excited by a convection or conduction heat transfer, or a metal element or other heat conductor that is energized to radiate heat by resistance heating by passing an electric current, or a suitable excitation source An ultrasonic element, such as an ultrasonic crystal element, that is adapted to emit sufficient ultrasonic waves to remove tissue when coupled may be included. It is also understood that those skilled in the art can readily adapt other known removal tools for use with the irrigated removal member.

In the described embodiment, the removal elements 50 are arranged one after the other on the length of the removal member 12 (ie, arranged in series in a spatial sense). The length from the closest electrode to the furthest electrode defines a removal length that is less than the operating length of the removal element, as described below.

At least one conductor lead 54 is connected to the electrode 52. In the described embodiment, the number of conductor leads 54 is preferably equal to the number of electrodes 50 so that each electrode 50 can be controlled independently under certain operating modes. Each conductor 54 is a 36 AWG copper wire insulated with a 0.0005 inch (0.0013 cm) thick polyimide coating. Each conductor 54 exits the electrical lead tube 30 at a point near the corresponding electrode 52. The end of each line is exposed and electrically connected to a corresponding electrode 52 as described below. The proximal end of each conductor lead 54 is connected to the electrical connector 38 at the proximal end of the tissue removal device assembly 10.

An irrigation mechanism irrigates the removal element 50. The irrigation mechanism is adapted to provide a generally uniform flow of fluid around each electrode along the length of the removal member. The irrigation mechanism releases fluid in either a radial (ie, generally perpendicular to the longitudinal axis) or longitudinal direction, or both, as indicated by the deformation described below the removal member. Can be configured for

The irrigation mechanism desirably includes an interior space 56 formed within a porous membrane 58 that is permeable to fluid. Preferably, the membrane 58 is generally tubular in shape and extends along at least a portion of the length of the removal member. However, the membrane 58 need not be tubular or need to cover the entire removal member 12. The membrane 58 is preferably configured to face the target tissue once the removal element 50 has been delivered into and positioned within a particular body space. In the described embodiment, the length of the membrane 58, as measured in the longitudinal direction, is greater than the distance between the closest and farthest electrodes in the series. The length of the membrane is defined between its near end 59 and far end 61.

The porous membrane 58 includes an inner surface and an outer surface that define a porous wall. The walls are constructed of a biocompatible, porous, non-compressible material as a whole. As used herein, the term "non-compressible" refers to a substantial compressibility, i.e., sufficient compressibility, between the inner and outer surfaces of the material so that it conforms to irregularities on the surface of the tissue on which the removal member 12 is to be placed. Is not shown as a whole. But the material is
Sufficiently longitudinally flexible so as to follow and along a guide member located within the left atrium, and more preferably within one of the pulmonary veins leading to the left atrium. (Ie, can be bent). In other words,
The material of the tubular porous membrane 58 directs the removal element 12 into the desired removal area.
Can be bent through a tortuous approach during in vivo delivery. In the described embodiment, the porous membrane 58 is also unable to expand and remains generally constant with the removal element even when the interior space is pressurized with fluid.

Due to the porosity of the material of the membrane, a sufficient pressure difference between both sides of the membrane 58 allows fluid to permeate the membrane 58. Thus, fluid does not flow freely through the membrane 58. The porosity over the length of the membrane 58 is also preferably uniform. This uniformity is linked to the material's flow obstruction, so that the fluid exiting the member 12 flows uniformly over the entire outer surface of the membrane.

Examples of porous materials suitable for this application include expanded polytetrafluoroethylene (PTFE), porous polyethylene, porous silicon, porous urethane, and a densely woven Dacron. included. Such porous materials are manufactured, for example, using conventional techniques, such as blowing out the material or drilling small holes in the material. Desirably, the porosity of this material ranges between about 5 microns and about 50 microns. An acceptable form of porous PTFE material is commercially available from International Polymer Engineering of Tempe, Arizona under product code 014-03. This material has a relatively low pressure (
For example, it has been observed that when applied at about 0.35 kg / cm ² (5 psi)), fluid passes through the material. In one form, membrane 58 has an inner diameter of about 0.147 cm (.147 cm) for applications involving removal of myocardial tissue via an arterial or venous access route.
About 0.058 inch) It is made with a tubular extrusion of this material at 172 cm (about 0.068 inch). For other applications, such as, for example, removal in small coronary arteries, sufficiently small diameter dimensions can be used.

As described above, the porous membrane 58 is attached to the distal end portion 20 of the delivery member. In the described embodiment, the proximal end 59 of the porous membrane is connected to the distal end portion 20 of the elongated body and the sealing member 60, as best understood from FIGS. 2, 2A and 3. It is located between them. That is, the tubular proximal end 59 of the porous membrane rests on the distal end 20 of the elongated outer tube 28 of the body. Thereafter, the sealing member 60 is slid over the assembly and positioned so as to ride generally over the overlapping portion of the tube 28 and the membrane 58.

The sealing member 60 is desirably constructed of a material similar to or compatible with the material of the elongated body 20 in order to heat seal the elongated member 20 together. In one embodiment, the sealing member 60 has the same grade of Pebax used for the outer tube of the elongated body 29.
This joining operation is performed at the proximal end 59 of the porous member disposed between the outer tube distal end 20 and the sealing member.

The porous membrane 58 also desirably includes one or more openings 62 through its wall. The openings 62 are formed at the proximal end of the membrane 58 prior to the bonding operation (eg, by punching) and in the form of holes or longitudinal slots extending from the proximal end into the membrane. Can take. Of course, other forms of openings can be used. As best shown in FIG. 2A, a sealing member 60 of similar plastic material and an elongated body outer tube 2 under and over the membrane 58 during the bonding operation.
8 are fused together in their openings. This bonding secures the porous membrane 58 to the distal end of the elongated body 28.

The porous membrane 58 can of course be joined to the elongated distal end portion 20 by any of a variety of other methods well known to those skilled in the art. For example, the proximal end 59 of the porous membrane 58 may be replaced with, for example, L-type, Rockyhill, CT.
The outer tube distal end 20 can be joined using a biocompatible adhesive, such as cyanoacrylate, commercially available as part number 498 from Octite®.

An end cap 64 closes the distal end of the porous wrap 58. The end cap 64 is desirably tapered such that its diameter decreases with distance.
On its distal end, the end cap 64 includes a port that aligns with the distal end of the guide tube 34 when assembled. End cap 64 also includes an internal opening partially formed by collar 65. The inner diameter of the coil section 65 is sized to receive the tubing 30, 32, 34, and the outer diameter of the collar is the outer end 6 of the porous curtain.
It is sized to slide into one.

The end cap 64 is preferably made of a biocompatible plastic material, such as, for example, urethane or vinyl. In a preferred embodiment, the end cap 64 is made of the same material that makes up the outer body of the elongated body, such as Pebax, graded between 3533 and 7233, and whose outer diameter is About 0.
163 cm (about 0.064 inch).

Preferably, the end cap 64 and the distal end 61 of the porous membrane 58 are secured together in the same manner as described above. Therefore, the second sealing member 60 and the distal end cap 64
During the heat fusion, the distal end of the porous membrane 58 is located between the elements. Similar plastic materials for the sealing member 60 and the end cap 64 are fused together at the distal end of the porous membrane and above and below the porous membrane within the opening of the membrane. Other joints can be used as described above.

As best seen in FIG. 3, each of guide member tube 34, fluid tube 32, and lead tube 30 extend longitudinally within porous membrane 58 to distal end cap 64. ing.

The electrical lead tube 30 functions as a wiring harness and supports one or more conductors 54 or wires attached to the electrodes 52. In the described embodiment,
The tube extends beyond the distal end portion of the elongated body and extends through the porous membrane 58 and terminates at a point in the distal end cap 64. A plug 66 seals the distal end of the electrical lead tube. In one embodiment, the stopper 66 is formed by filling the tube with Cyanoaerylat®.

The guide member tube 34 extends completely through the removal member 12 and the distal end cap 64 and into a distal port 67 formed in the end cap 64. The distal port 67 is sized to receive the elongated body 16 and the guide member over which the removal member 12 follows. Thus, the port allows the guide member to pass through end cap 64. In a modification of the described construction, the guide member tube 34 can replace the end cap with a porous membrane that is directly attached to the tube 34. In such an embodiment, another tube prevents shortage of the distal end of the removal member.

[0079] The fluid pipe 32 forms a compressible fluid passage. In the described embodiment, the fluid conduit 32 extends beyond the distal end portion of the elongated body and through the porous membrane 58 to a point in the distal end cap 64 next to the distal end of the electrical lead tube. Terminated. Another plug blocks the distal end of the fluid tube. In one embodiment, the stopper is a Loc at the distal end of the tube.
It is formed by filling Tite (registered trademark). However, the tube 32 can terminate near the electrode 50 and away from the nearby membrane seal.

The fluid tube 32 includes at least one opening 68 that opens into the internal space 56 formed in the porous membrane 58. In this way, a compressible fluid passage or lumen constituted by the irrigation tube communicates with the interior space 56 of the removal member. In the described embodiment, one slot 68 is formed near the proximal end of the interior space 56. However, some slots or holes can be formed along the irrigation tube extending through the interior space.

The proximal end 55 of the interior space is preferably sealed to prevent fluid flow nearby. In this variant, the far end 57 of the internal space is also sealed. This can increase the pressure in the interior space 56 and promote the seepage of fluid through the walls of the porous membrane 58, as will be described in more detail below. Appropriate sealing is performed by the above sealing technique. In another sealing technique, each location can be sealed by depositing heat shrinkable polyethylene terephthalate (PET) around the tube. The outer diameter of the near seal is large enough to block the passage therethrough at the distal end of the elongated body, the outer diameter of the seal being formed from the collar in the distal end cap 64. It is large enough to close the opening.

As can be seen from FIG. 3, each electrode 52 in the described structure has a helically wound wire coil. The electrodes 52 preferably have the same structure,
Accordingly, it is understood that the following description of one applies equally to all, unless otherwise specified.

Each coil electrode 52 has a sufficient inside diameter to receive the tubes 30, 32, 34, and the outside diameter of those tubes is sized to fit within the tubular membrane 58. In an example of this embodiment, each removal element 50 is made of a biocompatible material (eg, stainless steel, platinum, gold plated niteinol, etc.) having a diameter of about 0.005 inches (0.0012 cm). Line. The wire is unobstructed and spirally wound with an inside diameter of about 0.048 inches. The coils 52 are also separated along the length by tubes 30, 32, 34 extending longitudinally through the unique membrane 58. In one example of the embodiment, each coil 52 has a length, measured in the longitudinal direction, of about 0.71 cm (about 0.28 inch) and about 0.20 cm (about 0.08 inch) from the adjacent coil. Separated by a distance.

A corresponding conductor wire 54 passes through the electrical lead tube 30 and is soldered to the coil with 95Ag / 5Sn. The conductor wire 54 can also be electrically connected to the electrode 50 by other means such as, for example, resistance welding, ultrasonic welding or laser welding. Also, the coil and the conductor can be integrated by spirally winding the distal end of the conductor. Known electrical connectors can also be used to electrically couple the conductors to the corresponding electrodes.

The electrode 52 of the removal member desirably has sufficient flexibility to follow the vein access path to the target location for removal. The coil structure shown in FIG. 3 provides such flexibility. However, the electrodes 53 can take other shapes that provide similar flexibility. For example, as can be seen from FIG. 4A, the electrode 48 can take the form of a tubular or cylindrical shape formed by a plurality of braided lines. End bands 53 connect the ends of the wires together to prevent the braided structure from unraveling. The end band 53 can also electrically couple the wires together. Nevertheless, the bands are sufficiently thin so as not to significantly reduce the flexibility of the removal element 50. Any woven pattern will work, but a "diamond" shaped mesh is preferred. The cross-section of the braided line can be rectangular ("flat") or circular. The wire material can be any of a wide range of known materials that are compatible with living organisms, such as those specified above in connection with the coil electrode. In one aspect, the braided electrode can be "wrapped" before being inserted into the tubular porous membrane. Once inserted, the coil can be unwound and pressed against the inside surface of the tube. In this way, the membrane can support the electrodes.

FIG. 4B shows an electrode structure in which the electrodes 49 are formed from flat lines wound in an arc-shaped structure. In the illustrated form, the structure is semi-cylindrical, but the structure can be extended in a more or less arcuate manner.

FIG. 4C shows an electrode 51 in the form of a “fish bone”. The electrode 51 includes a plurality of arcuate portions extending from an elongated portion that extends generally parallel to the longitudinal axis of the cutting member when the member is assembled. The ends of each arc can be square (as shown) or circular.

FIG. 4D shows the electrode 72 formed in an “arch” shape. A plurality of arches are arranged in series on two side rails 74 interconnecting the corresponding ends of the arches. The arches are spaced from one another along the length of the electrode. 4C and 4
The embodiment of the electrode shown in D can be formed by etching a tube of electrode material or cutting with a laser.

What is common to all of the illustrated electrodes is that they can bend. The flexibility of these electrodes allows them to bend sharply in the entry path to the vein or artery without collapsing. The electrodes also have a low profile to minimize the outer diameter of the ablation member 12. Fluid may also flow radially through electrode 50. Other types of electrode configurations exhibiting these characteristics can also be used. For example, a conventional stent can be prepared by etching a tube or cutting with a laser.
) Can be formed in a similar manner. The electrodes need not extend all around the longitudinal axis of the ablation member; the electrodes are generally flat and can be placed on only one side of the catheter. The serpentine shape results in such a flat electrode with the desired flexibility. However, to reduce sensitivity to the orientation of the cutting member, it is desirable that each electrode extend at least 180 degrees around the longitudinal axis of the cutting member. Thus, the electrode configurations described so far are only examples of the types of electrodes that can be used in this cutting member.

Although the following variations of the irrigation and resection member 12 have been described as including the coiled electrode 52, any of the configurations described above, and variations thereof, can be used with those devices as well.

[0091] The tissue resection instrument assembly 10 also preferably includes a feedback controller. For example, ablation member 12 can include one or more thermal sensors 70 (eg, thermocouples, thermistors, etc.) provided outside or inside porous membrane 58. The monitor temperature at this location provides an indication of the progress of the lesion. The number of thermocouples 70 is
Preferably, it is equal to the number of electrodes 52 so as to enhance independent control of each electrode.
Assuming that the temperature sensor is located inside the porous membrane 58, feedback control may be required to account for any temperature gradient that occurs across the membrane. Sensors located outside the porous member can also be used to record electrogram signals by reconnecting signal leads to different input terminals of the signal processor. These signals are useful in taking a map record of the target tissue before and after removal.

In the described embodiment, each temperature sensor 70 has a tubular thermocouple located around the outside of the porous membrane 58. At this location, the thermocouple 70 is located outside the membrane 58, where it can directly contact the tissue-electrode interface. Thermocouple 70
Are separated from direct metal-to-metal contact with electrode 52. The reason is that the thermocouple is separated from the porous membrane 58. Therefore, it is not necessary to separately insulate.

As can be seen from FIG. 2, the thermocouple 70 is preferably mixed with the outer surface of the removing member 12 so as to make the contour smooth. In the mode shown, the transition region 72 formed by the adhesive or dissolved polymer tubing is "removed" by the removal member 12 such that its surface steps up from the outer surface of the outer porous member to the thermocouple surface. "

The signal line 42 extends from the thermocouple 70 to the electrical connector 39 on the proximal end of the tissue removal instrument assembly 10. In the state shown, the wire 42 is covered, extends to the porous membrane 58 and is within the electrical lead tube 36. These lines 74 may be routed in close proximity in other ways. For example, the lines 74 may be formed as a mesh external to the removal member 12 and may be routed close together along the sides of the body that is drawn out and elongated. Line 74 can also be routed proximate the inside of one or more tubes that extend parallel to or are adhered to the elongated body. Line 7
4 may be sewn into the wall of the outer tube of the elongated body. These can be replaced by a few alternatives in a variety of ways to route thermocouple wires to the proximal end of the tissue removal instrument assembly.

In use, the electrical and fluid connectors of the proximity coupler are connected to a removal actuator and a source of compressed fluid, respectively. A conventional ground patch or other ground device is located opposite the patient.

[0096] Patients diagnosed with focal arrhythmia due to the arrhythmia source, or with a primary lesion in the pulmonary vein, may have venous wall tissue, including both the arrhythmia source and the arrhythmia source and the left atrium. It is addressed by the tissue removal device assembly 10 of the present invention by using the assembly 10 to form a long conductive block along the path. In the former case, the arrhythmic tissue that was the source is destroyed by the conduction block because it has formed through the focal point. In the latter case, the focal point of the arrhythmia is that even if such abnormal conduction does not enter or affect the tissue of the atrial wall due to disturbing longitudinal conduction blocks, Still may conduct abnormal conduction.

The removal method of the present invention includes disposing the removal member 50 in a removal region along the pulmonary vein, and removing a region of tissue continuous between the pulmonary veins as the removal region.

In positioning the removal member 50 in the removal area, the distal end of the introducer catheter may be trans-accessible, as described in more detail below.
Inside the left atrium, it is first positioned and passed through the oval (fossa ovalis). The right vein system consists of a shell in which the surrounding veins (such as the femoral veins) are injured with a needle and the punctured wound is expanded by a dilator to a size sufficient to accommodate the delivery sheath. First accessed using Seldinger technology.
The delivery sheath has at least one hemostasis valve and is secured to the perforated wound that has been expanded to maintain relative hemostasis. Once the delivery sheath is positioned, the introducer catheter or sheath is delivered through the hemostasis valve of the delivery sheath and travels along the surrounding veins, into the region of the vena cava, and into the right atrium.

[0099] Once in the right atrium, the tip of the guide catheter is located opposite the oval at the septum wall in the atrium. A "Brochenbrough" needle or trocar is then advanced distally through the guide catheter and pierces the oval. A separate dilator also passes through the oval with the needle to create an access through the septum for anchoring the guide catheter. The guide catheter is then secured to the left atrium through the oval circle, across the septum instead of the needle, thereby allowing the intended device to pass through its own inner lumen into the left atrium. A passage is provided.

[0100] It is also contemplated that other left atrial passage methods may be utilized for use with the tissue removal device assembly of the present invention. In one other variation, a "reverse" approach may be used where the guide catheter is advanced from the arterial system into the left atrium. In this variation, the Seldinger technique is used to obtain a passage of blood vessels to the arterial system, such as in the femoral artery, rather than the venous system. The guide catheter is retracted through the aorta, surrounding the aortic arch into the left ventricle, and then advanced through the mitral valve to the left atrium.

After gaining access to the left atrium, the guide member is advanced into the pulmonary vein. This is typically done with a guide catheter secured to the oval. In addition to the left atrial passage guide catheter, a guide member according to this variant may be coaxial with a guide catheter using one of the directional catheters disclosed, for example, in US Pat. No. 5,575,766 to Swartz. Second sub-selective output catheter
It may be advanced to the pulmonary vein by being guided into the vein using a delivery catheter). Alternatively, the guide member may have sufficient rigidity and handleability within the left atrial cavity to solely subselect the desired pulmonary vein at the distal end of the guide catheter secured to the oval. Good.

The structure of the guide member suitable for use in the general tissue removal device assembly of the present invention may be selected from known structures. In general, any suitable choice is relatively stiff and radiopaque, sharp distal end with a rotatable base suitable for manipulating the sharp tip under radiography. Will include. The guide member is 0.0
Preferably, it has an outer diameter in the range of 10 inches to 0.035 inches. When the guide member is used to bridge from the guide member at the oval to the atrium,
If other secondary selection guide catheters are used, guide members having an outer diameter in the range of 0.018 to 0.035 inches are required. Guide members in this size range provide sufficient stiffness and handleability to allow the guide members to control and prevent unwanted escape of the guide members into the relatively open atrial cavity. It is considered necessary.

[0103] Following access to the pulmonary vein, the distal end of the tissue removal device assembly 10 follows over a guide member and enters the pulmonary vein. The removal element 50 is located in a removal portion of the pulmonary vein where the conduction block is preferably formed. Good contact between the removal element and the underlying tissue facilitates making a continuous transural wound.

Once the removal member 12 is positioned at the desired removal site, the output of RF energy to tissue within the heart of the pulmonary veins is initiated. RF energy from removal actuator 40 is output to electrode 52 via electrical lead 54. At the same time, a conductive fluid, such as a salt solution, is introduced into the fluid coupler 46 and passes through the fluid lumen 26. For example, it may be desirable to begin applying a positive fluid pressure to prevent blood build-up in or on the removal member 10 even before RF removal has begun.

In one form, saline passes from opening 68 in fluid conduit 32 to interior space 56 in porous membrane 58. When the pressure in the internal space 56 reaches a predetermined pressure, the fluid drops from the porous membrane 58. Not only does the fluid not flow directly through the porous membrane 58,
The fluid remains in the interior space 56 until the predetermined pressure is reached, so that the fluid
0 can be distributed evenly along the longitudinal length. This results in both a uniform flow over the length of the porous membrane 58 and a uniform flow of RF energy along the removal element 50. That is, the porous membrane 58 diffuses the saline over both ends of each individual electrode, as well as on both ends of the electrode array. A conductive fluid, i.e., saline, is used to form a uniform conductive path between the electrode and the target membrane, and the saline can be used to selectively or additionally cool the removal electrode. Used. The fluid passes through the helical coil of the removal element 50 and flows between the plurality of removal elements 50 of the removal member 12, thereby facilitating the cooling of the electrode 52 by the fluid. A saline bath may be able to cool the electrodes to allow for high levels of flow delivery and to allow for long lasting to create deep wounds.

When the target point is wound, the guide catheter moves to another position and an additional wound is formed.

While obtaining the above advantages, the removing member 12 can be configured in other forms. For example, as depicted in FIGS. 5 and 6, the removal member 12 can include a different shaft configuration than described above. Each of these embodiments will be described below. In the following description, in order to show similar parts between each removing member and the removing member described above, "
Similar reference numbers using the suffix "a" or "b" are used.
Therefore, it should be understood that, unless otherwise indicated, the above description of similar components applies to components in the following embodiments as well.

Referring to FIG. 5, the guide member tube 34a extends longitudinally through the removal member 12a and communicates with the formed distal end 67a of the end cap 64a. The guide member tube 34a is arranged in the structure of the braided wire 76.

[0109] The knitted structure 76 preferably includes at least an inner or outer coating of a resin material to form a pressurizable fluid flow path. In the shape shown, the inner and outer layers of polymer cover the knitted structure to form a common fluid impermeable structure. The polymer layer terminates at the distal end 20 of the extended body. The braided structure 76 continues to the distal end to form a support structure for the removal member 12a. Fluid can pass through the uncoated knitted structure.

The knitted structure supports the electrode 52a. The electrodes 52a are spaced along the length of the knitted structure to form a linear removal element. One of the wires 54a of the knitted structure 76 is connected to the corresponding electrode 52a. Any of the connectors described above can be used to electrically connect the uncoated ends of the conductive wires to corresponding electrodes.

Although not shown, spacers may be positioned adjacent to the electrode pairs to prevent flow through the corresponding areas of the knitted structure that are not covered by electrodes. The spacer can be formed of a polymer or epoxy attached directly to the braided structure. However, the lack of spacers allows the fluid flow between electrodes 50 to be beneficial in certain applications.

[0112] The porous membrane 58a covers the electrode 52a supported by the braided structure 76. The proximal end 59a of the porous membrane 58a is rigidly secured to the elongated body distal end 20a such that it is bounded by the thin-layered distal end. The proximal end 59a of the porous membrane may be attached by any of the methods described above.

[0113] Similarly, the far end 61a of the porous membrane 58a is attached to an end cap 64a. The end cap 64a has an extended collar 65a that receives the distal end of the braided structure. The distal end of the porous membrane 61a extends beyond the collar 65a and is securely fixed thereto by any of the methods described above.

The removal member 12a may also include one or more thermocouples. Thermocouple 7
Oa is attached to the porous membrane 58a by the method described above. In the species shown, the thermocouple wire 42a extends through the porous membrane 58a, through the knitted structure 76, and is routed near the inner lumen of the knitted structure forming a compressible fluid passage. . The proximal end of the thermocouple wire is connected to an electrical connector of a near coupler (as shown in FIG. 1).

A removal member 12b of the type shown in FIG. 6 has a protruding shaft 82 that includes a plurality of lumens. This shaft 82 can be formed from Pebax or other suitable flexible thermoplastic. As best seen in FIG.
2 is a guide member lumen 22b, a fluid lumen 26b, and an electric lead lumen 24.
b and three lumens. These lumens are arranged side by side, but two or three of the lumens 22b, 24b, 26b may be coaxially arranged. The plug 66b is connected to the electric lead lumen 24b and the fluid lumen 2
6b is closed at the far end.

[0116] The shaft 82 supports the electrode 52b. The electrodes 52b are spaced along the length of the shaft 82 to form a straight removal member 50b. The conductor leads 54b extend through the wall of the shaft 82 from the electrical lead lumen 24b to a point near the corresponding electrode 54b. Any of the connectors described above can be used to electrically connect the unshielded ends of the conductor leads to the corresponding electrodes 52b. Each electrical lead 54b is connected to a near coupler 36 located at the proximal end of the tissue removal instrument assembly (see FIG. 1).

The porous membrane 58b covers the electrode 52b supported by the protruding shaft 82. The proximal end 59b of the porous membrane is securely sealed around the outer surface of the shaft 82, and the distal end 61b of the porous membrane is secured around the shaft at a point near the distal end of the shaft 82. Sealed. The end of the porous membrane may be attached to the shaft in any of the ways described above.

The removal member can also include one or more thermocouples 70b. Thermocouple 7
Ob is attached to the porous member 58b in the manner described above. In the species shown, thermocouple wire 42b extends through porous membrane 58b, through a hole in shaft 82 that opens into electrical lead lumen 30b, and passes near lumen 30b. The proximal end of thermocouple wire 42b (as shown in FIG. 1)
It is coupled to the electrical connector 38 of the near coupler 76.

The shaft 82 also includes an opening 68b located just distal to the annular attachment of the porous membrane proximal end 59b to the shaft 82. The opening 68b extends from the fluid lumen 26b and opens into an internal space 56b formed in the porous membrane 58b. In this manner, fluid can flow from the fluid lumen 24b into the interior space 56b so as to pressurize the interior space 56b before passing through the porous membrane 58b as described above.

In each of the above-described modifications of the removing member 12, the porous film 58 covers the electrode 52. However, the porous membrane can be placed inside or below the electrodes, as long as it continues to supply a uniform current to each electrode. This change can be incorporated in each of the modifications described above. Thus, by way of example, a porous membrane 58c disposed between the electrode 52c and the braided structure 76c is shown in FIG. However, in other respects, the general structure of the removal member 12 is generally the same as the removal member shown in FIG. Accordingly, corresponding reference numerals with the suffix "c" have been used to indicate corresponding components between these two embodiments. The foregoing description of such corresponding components is also meant to apply, unless otherwise indicated.

As can be seen from FIG. 7, the porous membrane 58c is disposed on the braided structure 76c. Electrode 52c is disposed around braided structure 76c and porous membrane 58c. As shown in FIG. 7, the removal member 12c has a reduced diameter where the electrode 52c is located so that the contour along the distal end of the tissue removal device assembly is generally uniform. It is desirable that there is a part. In this portion, a spacer 84 can be arranged between a pair of adjacent electrodes. As described above, such a spacer 84 causes the fluid to flow through the porous membrane 58 at a location other than where the electrode 52c is disposed.
c to prevent it from flowing through. However, the removal member does not
In order to generate a fluid flow between 0a, it can be configured without a spacer.

FIGS. 8 to 10 show other modified examples of the removing member. Referring to FIG. 8, the illustrated removing member has the same structure as the removing member illustrated in FIG. Here again, the corresponding reference numerals with the suffix "d" are used, with the understanding that the preceding description should equally apply to such components of the present variant, unless otherwise indicated. Used to indicate similar components during the embodiment of FIG.

In the variant shown, the distal end 85 of the removal member 12d is open while
It is desirable to have a tapered diameter 86. The tapering of the diameter reduces the pressure in the fluid passage so that at least some of the fluid in the passage exits radially past electrode 52d through braided structure 76d and porous membrane 58d. It is possible to wake up inside.

The braided structure 76d forms a support for the porous membrane 58d over its entire length. Although not shown, other supports may be used. For example, an inner or outer ring can be spaced at various points along the length of the porous membrane to further support the porous membrane. Alternatively, a mandrel can be used for this purpose. The proximal end of the mandrel is surrounded by a laminar structure and may protrude at the distal end.

FIG. 9 shows a modification of the removing member shown in FIG. Fluid transfer tube 90
Is positioned within the braided structure 76d and is movable by its proximal end (not shown) located outside the patient to reposition the distal end of the tube 90. The distal end of tube 90 has one or more openings 92 that allow fluid to be transferred into a pressurizable passage by tube 90. By moving the distal end of the fluid tube 90, the amount of fluid flowing over a particular electrode 52d can be varied. To further facilitate this effect, the fluid tube 90 may include a stop 94 disposed proximally and distally of the fluid opening, as shown in FIG. These prevention members 94 are made of a porous film 58d.
Increase the radial flow rate of fluid through the Of course, these features can also be incorporated into some of the other variations described above.

So far, modifications of the removal member used to form a linear removal of body space have been described. The removal member can be incorporated into various delivery devices such that the removal member is located at a location in body space. At least one of the near end portion and the far end portion of the removing member is connected to the delivery device. The end is easily manipulated in body space by manipulating the proximal end portion of the delivery device.

FIGS. 11 to 13 show a removal member 12 attached to an exemplary variation of the delivery member for application to body spaces such as the right and left atriums.
FIG. 11 shows that the removal member 12 is attached to the distal end portion of an elongated catheter body 98. The body 98 has a guide member opening 100 at a portion near the removing member 12. The distal end portion of the device is provided with a lumen portion 102, a guide member tracking member, for receiving and withdrawing the guide member 104 again. The guide member 104 is provided with a stop 106. At a predetermined location, the distal end portion of the removal member 12 can contact the stop 106. Any further movement between the elongated body 98 and the removal member 12 will cause the removal member 12 to bow outwardly from the guide member 104.

FIG. 12 shows a modification of another delivery member. The delivery member comprises at least two guide member tracking members 108,112. First member 1
08 has an outlet 110 located at the proximal end portion of the removal member 12. The first guide member tracking member 108 also includes an inner lumen that extends proximate to either the proximal end portion of the catheter for over-the-wire applications and a position slightly closer to the removal member for "quick replacement" applications. Having. Second guide member tracking member 11
2 has a guide member lumen extending through the removal member 12 and terminating at the distal end portion 114 of the catheter.

FIG. 13 shows a modification of another exemplary delivery device. The device includes first and second delivery members 116, 118. In the illustrated embodiment, the delivery member 11
6, 118 are over-the-wire catheters. However, other types of catheters can be used. The removal members 12 are located between the delivery members and are mounted near the distal end portion of each delivery member. Preferably, the entire assembly is provided in a jacket 120 that can extend through, for example, a cuff-shaped sheath.

In the variation of the delivery member shown in FIGS. 12 and 13, the anchor is used at two target tissues relative to the removal member. For example, in a modification of the delivery member shown in FIG. 12, each guide member functions as an anchor. In applications where multiple lumens communicate with body space, for example, in the left atrium where the pulmonary veins communicate with the heart,
The guide member 104 can be guided into a plurality of lumens to function as an anchor. In addition, other types of anchor devices can be used. For example, an inflatable balloon 122 or an inflatable basket (as shown in FIG. 13) can be used at two locations in the targeted body space to secure the removal member 12.

FIGS. 14 and 15 show additional variations of the tissue removal device assembly. This variant is
It allows the use of existing removal members 12 with existing removal devices and tip electrode catheters. The flexible sheath 124 or sleeve has at least two
And two lumens 126,128. One lumen 126 is provided for the catheter 13
It is sized to allow a 0 catheter shaft to slide in. The other lumen 128 is disposed next to the first lumen 126 and communicates with a fluid port 129 disposed substantially at the distal end of the sheath 124. The flexible body 124 may be formed in various shapes such as a multi-tube, a layered knitted structure, or a multi-lumen projecting shaft member.

A porous membrane 132 is located at the end of the sheath. This porous membrane is a porous membrane 5
Desirably, 8 is designed substantially according to one of the variants described above, which creates a void therein. However, the electrodes have been omitted from this embodiment. The void inside the sheath 124 is adapted to receive the distal end of the catheter 130 containing the removal element 50. For this purpose, the first lumen 126 opens into an internal cavity. A fluid lumen also communicates with the interior cavity to supply pressurized fluid to the cavity between the catheter removal element 50 and the porous membrane 132. The tip of the porous membrane 132 can be closed by an end cap 134 as shown, or can be left open, similar to the structure shown in FIG.

[0133] In use, the electrodes of the catheter 130 are positioned within the first lumen of the sheath and advanced until the removal element is located within the porous membrane. Although this is preferably done before reaching the destination, in some applications the sheath can be pre-positioned with the catheter advancing through the underlying sheath, or can be left in place .

To add the proper positioning of the removal element 12 into the porous membrane, the catheter tip and the porous membrane will show signs that coincide with each other as soon as the tip of the removal member is advanced to a location in the membrane. It is desirable to include. For in vivo applications, such indications may take the form of radiopaque landmarks located at corresponding locations on catheter 130 and porous membrane 132 (or another location on the sheath).

Although the present invention has been described in terms of certain preferred embodiments, it will be apparent to one skilled in the art that other embodiments are within the present invention. Accordingly, the scope of the invention is intended to be limited only by the appended claims.

[Brief description of the drawings]

FIG. 1 is a perspective view of a tissue removal instrument assembly having a irrigated removal member configured in accordance with a preferred variation of the present invention.

FIG. 2 is an enlarged perspective view of the irrigated removal member of FIG. 1 with a portion of the resection member cut away.

FIG. 2A is an enlarged cross-sectional view of a portion of the cutting member of FIG. 2 taken along line 2A and 2A.

FIG. 3 is a partial cross-sectional perspective view of the removal member to be irrigated in FIG. 2, illustrating a series of electrode coils in the removal member.

4A-4D are diagrams illustrating other variations of the electrode configuration that can be used with the cutting member of FIG.

FIG. 5 is a cross-sectional, side view of an irrigated removal member constructed in accordance with another preferred variation of the present invention.

FIG. 6 is a cross-section of an irrigated removal member, constructed in accordance with an additional preferred variant of the present invention;
It is a side view.

6A is a cross-sectional view of the removing member taken along the line 6A in FIG. 6; FIG.

FIG. 7 is a cross-sectional, side view of an irrigated removal member constructed in accordance with another preferred variant of the invention, having electrode elements disposed on the outer surface of the porous member.

FIG. 8 is a cross-sectional, side view of an irrigated removal member constructed in accordance with another preferred variation of the present invention having a liquid outflow port positioned on the distal end of the irrigated removal member.

FIG. 9 is a cross-sectional, side view of an irrigated removal member configured in accordance with another additional preferred variation of the present invention having a slidable fluid delivery tube disposed within the cutting member.

10 is another preferred variant of the present invention, similar to the removal member shown in FIG. 9 with additional blocking material located on the proximal and distal sides of the outlet opening of the fluid delivery tube. FIG. 4 is a cross-sectional, side view of an irrigated removing member configured according to the above.

FIG. 11 is a side view of a removing member disposed at the other end of the delivery member.

FIG. 12 is a side view of the removal member located at the distal end of the additional deformation of the delivery member.

FIG. 13 is a perspective view of a removal member disposed at a distal end of another variation of the delivery member.

FIG. 14 is a schematic illustration of another variation of an irrigated tissue removal device assembly according to another preferred variation of the present invention.

FIG. 15 has a typical catheter positioned within the device shown in FIG.
It is a schematic explanatory drawing of the device concerned.

──────────────────────────────────────────────────続 き Continuation of front page (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE ), OA (BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, MW, SD, SL, SZ, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AL, AM, AT, AU, AZ, BA, BB, BG, BR , BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS , JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, MG, MK, MN, MW, MX, NO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, UA, UG, UZ, VN, YU, ZA, ZW (72) Inventor Valentia, Aurelio United States 94303 East Palo, California 94303 Alto Clark Avenue 2249 F-term (reference) 4C060 EE30 KK50 MM24

Claims (48)

[Claims] 1. A generally incompressible member having a removal member including at least one removal element, at least one conductor coupled to the removal element and extending proximally from the removal element, and an inner surface defining an interior space. At least one porous membrane having a porous wall disposed relative to one another with respect to the removal element; and at least one fluid passage communicating with the interior space; The porous membrane allows a volume of fluid to flow from the inner space through the porous wall into the outer space surrounding the porous wall without changing the relative arrangement between the porous wall and the removal element. The removal element is adapted to be adapted to be coupled in a manner to remove to a region of tissue via its volume of fluid flowing through the porous wall. Sufficiently close to being placed, the tissue removal tool assembly that is adapted to remove an area of tissue within a patient's body space wall film. 2. The tissue removal device assembly according to claim 1, wherein the at least one porous membrane is connected to and covers at least a portion of a removal member disposed within the interior space. 3. The porous membrane further comprises an outer surface surrounded by an outer space,
The tissue removal device assembly according to claim 1, wherein at least a portion of the removal element is disposed within the exterior space. 4. A first supply member having a first end portion and a second end portion, and a second supply member having a first end portion and a second end portion. A removing member coupled between a distal end portion of the first supply member and a distal end portion of the second supply member, wherein at least a portion of the removal member is a distal end portion of the first supply member. The tissue removal device assembly according to claim 1, wherein the portion extends between the portion and a distal end portion of the second supply member. 5. A first anchor disposed along a distal end portion of the first supply member and a second anchor disposed along a distal end portion of the second supply member. The tissue removal instrument assembly according to claim 4, further comprising: 6. The body of claim 1, further comprising an elongated body having a proximal end portion and a distal end portion, wherein the removal member is disposed along a distal end portion of the at least partially elongated body. Item 2. A tissue removal instrument assembly according to Item 1. 7. A removing member is disposed on a distal end of the elongated body,
The elongated body further comprises a first anchor and a second anchor, wherein the first and second anchors are arranged such that a removal member is located between the first and second anchors. 7. The tissue removal device assembly of claim 6, wherein 8. The tissue according to claim 5, wherein the at least one anchor comprises a guide member tracking member that engages the guide member to form a hole adapted to track the guide member. Removal instrument assembly. 9. The at least one anchor has a guide member proximal end portion, a guide member distal end portion, and a stop on the guide member distal end portion having a larger diameter than the guide member distal end portion. The tissue removal instrument assembly according to claim 5, further comprising a guide member. 10. The tissue removal device of claim 6, wherein the fluid passage extends between a near fluid port along a proximal end portion of the elongated body and an interior space within the porous membrane. Assembly. 11. A near fluid coupling adapted to connect a near fluid port to a compressible fluid source in fluid communication and a near removal coupling adapted to couple a conductor to a removal actuator. The tissue removal device assembly of claim 10, further comprising a device. 12. An elongate member further comprising a near-outer surface and a far-outer surface disposed remote from the near-outer surface, wherein the porous member includes a near-end portion sealed over the near-outer surface. A distal end portion encapsulated on the far outer surface, wherein at least a portion of each of the removal element and the incompressible porous wall includes a proximal end portion and a distal end portion of the porous membrane. The tissue removal instrument assembly according to any one of claims 6 to 11, wherein the tissue removal instrument assembly is disposed between. 13. The internal space may be provided with a fluid at a location remote from the removal member such that the compressed fluid is allowed to flow from within the interior space to the exterior of the removal member only through the incompressible porous wall. 13. Closure to prevent leakage
A tissue removal device assembly according to claim 1. 14. The tissue removal device assembly according to claim 13, wherein the elongated body includes a return passage communicating with a portion of the interior space within the porous membrane. 15. A distal end portion of the body that is at least elongated so that the removal member is disposed at a distal end portion of the elongated body and the removal element can be positioned at a predetermined location relative to the interior space. 12. The tissue removal device set of claim 6, 10 or 11, wherein a porous membrane is disposed along a distal end portion of the elongated sheath member adapted to slidably receive the sheath. Three-dimensional. 16. A delivery member having a near end portion and a far end portion, and extending between a near delivery port along a near end portion of the delivery member and a far delivery port along a far end portion of the delivery member. Further comprising a delivery lumen, wherein the far end portion of the delivery member is arranged in the body space by operating the near end portion of the delivery member, and the sheath member has a porous membrane. 16. The tissue removal instrument assembly of claim 15, wherein the tissue removal instrument assembly is slidably engaged within the delivery lumen so as to be advanced into the body space through the distal delivery port. 17. When the distal end portion of the sheath member and the distal end portion of the elongated body are disposed in the body space, the removal member can be controllably disposed relative to the internal space. 17. The tissue removal device assembly according to claim 15 or 16, further comprising at least one indicator for indicating the location of the distal end portion of the elongated body relative to the porous membrane. 18. A method according to claim 18, wherein the at least one indicator is a first marker opaque at a first location on the sheath member relative to the porous membrane, and is elongated relative to the removal element. A second marker opaque to the body located at a second predetermined location on the body, whereby the elongated body is slidably engaged within the sheath member. 18. The tissue removal instrument assembly according to claim 17, wherein sometimes the first marker that is opaque to X-rays is positioned relative to the second marker that is opaque to X-rays, and the removal member is positioned in place. 19. The sheath member further comprises a stop, wherein the stop is distal such that when elongated within the interior space, the elongated body cannot slide slidably away from the stop. So that the removal element is placed in place when the elongated body is engaged with the stop,
19. The tissue removal device assembly according to claim 15, wherein the porous wall and the removal element are disposed along the sheath member and the elongated body, respectively. 20. The elongate body further comprises an outer surface disposed distally of the removal element, and the sheath member further comprises a distal fluid port disposed distally of the porous membrane, and wherein the sheath member has an interior through the fluid port. The sheath member slides over the elongated body such that the space is open to the outside and at least a portion of the distal end portion of the elongated body extends farther from the interior space through the distal fluid port. 17. The tissue removal device assembly of claim 15 or 16 adapted to be received. 21. The sheath member further comprising a closed distal end, wherein the elongated body received within the sheath member is not adapted to advance beyond the closed distal end. The tissue removal device assembly according to claim 19. 22. The tissue removal device assembly according to claim 15, wherein the elongated body includes a plurality of passages extending from the proximal end portion to the interior space within the porous membrane. 23. The tissue removal device assembly of claim 22, wherein at least two of the plurality of passages are arranged in a side-by-side relationship. 24. The tissue removal device assembly of claim 15, wherein the sheath member further comprises a reinforcing member disposed within the interior space and configured to support at least a portion of the porous membrane. . 25. The tissue removal device assembly according to claim 1, further comprising at least one temperature sensor provided along the porous membrane. 26. The tissue removal device assembly of claim 1, wherein the incompressible porous wall comprises a polytetrafluoroethylene material. 27. The tissue removal device assembly according to claim 1, wherein the removal element comprises at least one electrode. 28. The tissue removal device assembly according to claim 27, wherein the electrode has a spiral shape. 29. The tissue removal device assembly of claim 27, wherein the electrode has at least one arcuate portion extending at least partially around a longitudinal axis of the removal member. 30. The tissue removal device assembly of claim 27, wherein the electrode has at least one portion extending generally parallel to a longitudinal axis of the removal member. 31. The tissue removal device assembly according to claim 27, comprising a knitted tubular structure including a plurality of conductive members. 32. The tissue removal device assembly according to claim 27, wherein the conductor is electrically connected to the electrode. 33. The tissue removal device assembly according to claim 32, wherein the electrode and the conductor are integral. 34. A compressible fluid source comprising a conductive fluid and connected to the fluid passage, wherein the porous membrane is adapted to be pressurized when the internal space is pressurized to a predetermined pressure by the conductive fluid. A tissue removal device assembly according to any of the preceding claims, adapted to allow the conductive fluid to flow from the interior space to the exterior of the removal member. 35. A plurality of removal elements arranged in a longitudinally spaced array along at least a portion of the removal member such that the removal element is adapted to remove a length of tissue. 35. The tissue removal device assembly of claim 34, further comprising: 36. The tissue removal device assembly of claim 35, further comprising a plurality of porous membranes each having a generally incompressible porous membrane having an inner surface covering at least one electrode. 37. The removal element has a first length, wherein a plurality of electrodes are spaced along the first length, and wherein the inner surface of the porous membrane is longer than the first length so as to cover each electrode. 36. The tissue removal device assembly of claim 35 having a second length. 38. The tissue removal device assembly according to claim 1, wherein the conductor forms at least part of an elongated braided structure. 39. The tissue removal device assembly according to claim 1, wherein the fluid passage is at least partially formed by an elongated tubular member. 40. The tissue removal device assembly according to claim 1, wherein the conductor and the fluid passage are arranged in a side-by-side relationship over at least a portion of their length. 41. The apparatus further comprises an elongated body having at least two lumens, one of the lumens defining at least a portion of the fluid passage, and the other lumen adapted to receive at least a portion of the conductor. 41. The tissue removal device assembly of claim 40. 42. The tissue removal device assembly according to claim 1, wherein the conductor and the fluid passage are at least partially coaxially disposed over at least a portion of their length. 43. The tissue removal device of claim 42, wherein the conductor forms at least a portion of the tubular braided structure, and wherein the fluid passage extends at least partially into the tubular braided structure. Instrument assembly. 44. The tissue removal device of claim 43, wherein the fluid passage is at least partially disposed within an inner lumen of the tubular member extending at least partially through the tubular braided structure. Instrument assembly. 45. The tissue removal device assembly of claim 44, wherein the tubular member and the tubular braided structure are at least partially combined in a composite structure. 46. Providing a first tubular member and a second tubular member, forming at least one opening in a section of the first tubular member, and said section of the first tubular member. At least partially disposed over the second tubular member; providing a sealing member of a material compatible with the material of the second tubular member; and providing at least a portion of said section of the first tubular member. Disposing the sealing member on the second tubular member to form a fused assembly, wherein a portion of the fused assembly is a first member. A method of making an elongated medical device extending through an opening formed in said section of a tubular member to secure the first tubular member and the second tubular member together. 47. The method of claim 46, wherein providing a first tubular member comprises providing a tubular porous membrane. 48. The method of claim 47, further comprising placing a tubular porous membrane around at least one removal element.